510(k) Report

FDA applicant

Naviswiss AG

Brugg, CH3 decisions2020–20230 recalls

FDA records 3 decisions for Naviswiss AG (Brugg, CH) from 2020 to 2023: 3 510(k) clearances. Most are in product codes OLO (Orthopedic Stereotaxic Instrument) and LLZ (System, Image Processing, Radiological). Since 2016 its 510(k)s took a median of 151 days from receipt to decision, against 90 for FDA’s reviews in the same codes and years. Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Naviswiss AG’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2020: 12021: 12023: 1
2020high 1 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Naviswiss AG by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OLOOrthopedic Stereotaxic Instrument2decisions
  • LLZSystem, Image Processing, Radiological1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 151 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 90 days; 0 of its 3 were faster than that.

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K193094Naviswiss Hip Navigation SystemNaviswiss AG · 20201cites it

What has FDA decided for it lately?

  • K223351Naviswiss KneeNaviswiss AG · 2023
  • K211429NAVIPLAN - CT Planning Software for Total Hip ReplacementNaviswiss AG · 2021
  • K193094Naviswiss Hip Navigation SystemNaviswiss AG · 2020

All 3 as Naviswiss AG →